Print Friendly Page

Protocol No. UW15063

Principal Investigator Deming, Dustin

Phase I

Age Group Adult

Scope Local

Sponsor Type Industry; Institutional

Title Pembrolizumab in combination with stereotactic body radiotherapy for liver metastatic colorectal cancer

Objective The purpose of this research study is to find out how safe the study drug, pembrolizumab, is when combined with stereotactic body radiotherapy (SBRT) to the liver, see how well subjects can tolerate treatment with pembrolizumab and SBRT and to find out how often colorectal cancer comes back 1 year after surgically removing all known disease and being treated with SBRT and pembrolizumab.

Treatment Treatment includes three sets of research imaging tests (FDG PET/MRI, FLT PET/CT) to visualize the cancer in your liver, SBRT to the cancer in your liver, surgery to remove the cancer in your liver, Pembrolizumab every three weeks by IV infusion for a total of 9 cycles and follow up activities after the pembrolizumab has been completed.

Description An FDG-PET/MRI is an advanced imaging study using magnetic resonance imaging (MRI) combined with positron emission tomography (PET). The study team is trying to get a better understanding of the advantages and disadvantages of using a PET/MRI scan when compared to standard CT/MRI scans when evaluating colon cancer that has spread to the liver and how it responds to certain anti-cancer treatment. After imaging has been completed, SBRT treatment will begin. SBRT visits typically occur every other day (M-F) for two weeks (total of 5 visits). Approximately 2 weeks after you have completed SBRT, you will receive the first dose of pembrolizumab, also known as KEYTRUDA. Pembrolizumab is a monoclonal antibody and is available by prescription to treat malignant melanoma. It is being studied to see if it is effective in treating more than 30 types of cancer and to see what side effects are associated with its use. This will be given as an intravenous infusion (IV) over approximately 30 minutes. You will meet with a surgeon to discuss surgical management (removal) of the known cancer in your liver. The surgery will be scheduled to occur 2-4 weeks after you have received the first dose of pembrolizumab.

Key Eligibility
  • Have a diagnosis of histologically confirmed metastatic colorectal cancer to the liver (no other sites of metastatic disease)
  • Tumor must be mismatch repair (MMR) proficient as determined by microsatellite instability or immunohistochemistry for MMR proteins
  • Patient must be a candidate for SBRT to at least one intrahepatic lesion. There is no limit on the number of intrahepatic lesions the patient may have
  • Patient must be a surgical candidate with therapeutic goal of eradicating all known disease with one additional surgery
  • Prior resection of extra-hepatic metastatic disease allowed if completed more than 12 months previous to study enrollment and no new extra-hepatic disease has been found
  • Subjects must have received at least one prior line of chemotherapy including an irinotecan or oxaliplatin-fluoropyrimidine-based systemic treatment for colorectal cancer
  • If patient has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study they are ineligible
  • Prior radiotherapy to the liver is not allowed
  • If patient has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent they are not eligible
  • If patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the initiation of SBRT they are ineligible
  • If patient has a known history of HIV, Hep B, Hep C or active TB they are ineligible
  • Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis are ineligible
  • Subjects with previously resected brain metastases may participate provided it has been at least 6 months and no CNS progression has been identified
  • Patients with a known history of, or any evidence of active, non-infectious pneumonitis are ineligible
  • Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent are ineligible

Applicable Disease Sites Colon and Rectum

Status Open

Participating Institutions UW Hospital and Clinics